Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.


Clinical Trial Description

RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03606512
Study type Interventional
Source Janssen Vaccines & Prevention B.V.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 21, 2019
Completion date November 2, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04528719 - A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive Phase 1
Terminated NCT02508194 - A Study to Evaluate the Efficacy of MEDI7510 in Older Adults Phase 2
Active, not recruiting NCT06060457 - A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age Phase 3
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Completed NCT00100373 - RSV Challenge in Healthy Adults N/A
Completed NCT03524118 - Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002) Phase 1/Phase 2
Active, not recruiting NCT05572658 - Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Recruiting NCT06067230 - A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults Phase 3
Completed NCT00246480 - RSV Disease in the Elderly
Active, not recruiting NCT06097299 - A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Phase 2
Completed NCT00889070 - Respiratory Events Among Premature Infants N/A
Unknown status NCT00613184 - Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses N/A
Completed NCT05559905 - Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017) Phase 2
Active, not recruiting NCT05127434 - A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age Phase 2/Phase 3
Terminated NCT04978337 - A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Phase 2
Recruiting NCT06143046 - A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers Phase 2
Active, not recruiting NCT05397223 - A Study of Modified mRNA Vaccines in Healthy Adults Phase 1
Completed NCT02472548 - A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine Phase 1
Completed NCT01734668 - Sofia RSV FIA Field Study N/A
Completed NCT01562938 - MEDI-557 Adult Dosing Phase 1